Prescribing Information

Pertzye (a combination of lipase, protease and amylase enzymes) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. Pertzye is not available as a generic. Pertzye may cause serious side effect including irritation of the inside of the mouth, increased uric acid levels in the blood, diarrhea, indigestion, cough, and allergic reactions.

Pertzye is available in 8,000 and 16,000 lipase units (USP). In children older than 12 months and younger than 4 years and weighing 8 kg or greater, enzyme dosing should begin with 1,000 lipase units/kg of body weight to a maximum of 2,500 lipase units/kg of body weight. In children older than 4 years and older and weighing 16 kg or greater and adults, enzyme dosing should begin with 500 lipase units/kg of body weight to a maximum of 2,500 lipase units/kg of body weight (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day. Pertzye should be taken with a meal or a snack. Pertzye should be given to a pregnant woman only if clearly needed. The risk and benefit of pancrelipase should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency. Adequate caloric intake during pregnancy is important for normal maternal weight gain and fetal growth. Reduced maternal weight gain and malnutrition can be associated with adverse pregnancy outcomes. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PERTZYE is administered to a nursing mother.

Our Pertzye Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

SIDE EFFECTS

The most serious adverse reactions reported with different
pancreatic enzyme products of the same active ingredient (pancrelipase) include
fibrosing colonopathy, hyperuricemia and allergic reactions [see WARNINGS
AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical trials of a drug
cannot be directly compared to the rates in the clinical trials of another drug
and may not reflect the rates observed in clinical practice.

The short-term safety of PERTZYE was assessed in a
randomized, double-blind, placebocontrolled, crossover study of 24 patients,
ages 8 to 43 years, with exocrine pancreatic insufficiency due to cystic
fibrosis. In this study, patients were randomized to receive PERTZYE at
individually titrated doses (not to exceed 2,500 lipase units per kilogram per meal)
or matching placebo for 6 to 8 days of treatment, followed by crossover to the alternate
treatment for an additional 6 to 8 days. The length of exposure to PERTZYE during
this study was 20-28 days, including the treatment period of 6 to 8 days, and
the open label titration and transition periods of 7 to 10 days.

The most common adverse reactions ( ≥ 10%) were diarrhea,
dyspepsia, and cough. Table 1 enumerates adverse reactions that occurred in at
least 2 patients (greater than or equal to 10%) treated with PERTZYE at a higher
rate than with placebo.

Table 1: Adverse Reactions Occurring in at Least 2 Patients ( ≥ 10%)

Adverse Reaction

PERTZYE
n=21
n (%)

PLACEBO
n=24
n (%)

Diarrhea

2 (10%)

1 (4%)

Dyspepsia

2 (10%)

1 (4%)

Cough

2 (10%)

1 (4%)

Postmarketing Experience

The following adverse reactions have been identified during
post approval use of PERTZYE. Because these reactions are reported voluntarily
from a population of uncertain size, it is not always possible to reliably
estimate their frequency or establish a causal relationship to drug exposure.

This formulation of PERTZYE has been marketed since 2004
under the trademark PANCRECARB®. Two product complaints relating to an adverse
drug reaction were reported. A mild allergic reaction (itching and red, blotchy
rash on face) was reported by a patient with a known history of allergy to
another pancrelipase product, and a dull headache was reported by another
patient taking concomitant ursodeoxycholic acid. Both events resolved without
sequelae after discontinuation of treatment.

Delayed- and immediate-release pancreatic enzyme products
with different formulations of the same active ingredient (pancrelipase) have
been used for the treatment of patients with exocrine pancreatic insufficiency
due to cystic fibrosis and other conditions, such as chronic pancreatitis. The
long-term safety profile of these products has been described in the medical
literature. The most serious adverse events include fibrosing colonopathy, distal intestinal obstruction syndrome (DIOS), recurrence of pre-existing carcinoma,
and severe allergic reactions including anaphylaxis, asthma, hives, and
pruritus. The most commonly reported adverse events were gastrointestinal
disorders, including abdominal pain, diarrhea, flatulence, constipation and
nausea, and skin disorders, including pruritus, urticaria and rash.